Majalah Kedokteran Bandung (MKB)

RESEARCH ARTICLE
Received: June 12, 2021
pISSN: 0126-074X | eISSN: 2338-6223 Accepted: February 12, 2022
https://doi.org/10.15395/mkb.v54n1.2452 Available online: March 31, 2022
Majalah Kedokteran Bandung. 2022;54(1):51–56

Comparison between the Effectiveness Fecal Immunochemical Test and

Colonoscopy As A Tool For Colorectal Cancer Early Detection
Yossi Andila, Reno Rudiman, Andriana Purnama
Departement of Surgery, Faculty of Medicine Universitas Padjadjaran
Dr. Hasan Sadikin General Hospital Bandung, Indonesia

Abstract

Cancer is a disease that causes a lot of misery and death in humans. According to data from the World Health
Organization (WHO) in 2015, there are 8.8 million deaths caused by cancer and colorectal cancer ranked third
with 774,000 deaths. One of the prevention effort for colorectal cancer is early detection in the population,
especially in high-risk groups and in groups with non-specific symptoms. In general, two types of early detection
tests are available: stool-based testing and structural testing. Fecal immunochemical test (FIT) is one type of
examination that is categorized as the tool-based test. Meanwhile, the structural test include colonoscopy,
CT colonography and flexible sigmoidoscopy. This study aimed to determine difference in the effectiveness
of FIT against colonoscopy as an early detection tool for colorectal cancer. This study was a cross-sectional
comparative diagnostic analytical observational study to compare FIT to colonoscopy for early detection of
colorectal cancer. This study involved patients presented to Dr. Hasan Sadikin General Hospital Bandung,
Indonesia. Analysis of diagnostic test data was carried out to obtain the sensitivity, specificity, and the positive
and negative predictive values through the use of bivariate analysis in the form of Man Whitney test. Thirty-
eight patients were included in this study, consisting of 27 cancer patients and 11 non-cancer patients. Results
showed that the sensitivity level of FIT was 81.5%, with 72.7% specificity. There is no significant difference in
the effectiveness between FIT and colonoscopy in screening for colorectal cancer.

Keywords: Cancer, colorectal cancer, colonoscopy, comparative studies, fecal immunochemical test

Introduction from colorectal cancer are bleeding in the lower

Colorectal cancer is a malignancy originating
from the large intestine, consisting of the colon
(the longest part of the large intestine) and/
or the rectum (the last small part of the large
intestine before the anus). According to the
American Cancer Society, colorectal cancer is the
third most common cancer and the third leading
cause of cancer death in men and women in the
United States. Based on the 2018 GLOBOCAN
survey (Global Burden of Cancer Study), the
incidence of colorectal cancer worldwide ranks
third (1360 out of 100,000 populations) and
ranks fourth as a cause of death (694 out of
100,000 populations).1
Colorectal cancer is generally more common
in elderly individuals and is very rare in children.
Suspicion of colorectal cancer can be seen based
on the symptoms experienced by the patient.
Symptoms that often arise in someone suffering
Corresponding Author:
Yossi Andila,
Departement of Surgery, Faculty of Medicine Universitas
Padjadjaran/Dr. Hasan Sadikin General Hospital Bandung,
Indonesia
Email: yossiandilla@gmail.com
Copyright @ 2022 by Authors. This is an Open Access article licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (http://
creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original
author and source are properly cited.
51
gastrointestinal tract, which is characterized by
bloody discharge during defecation, an increase
in the number of feces produced and often
accompanied by diarrhea that lasts for more than
6 weeks. In addition, other symptoms are signs
of blockage in the intestines and the occurrence
of weight loss for no apparent reason.1,2
Colorectal cancer/carcinoma can be
diagnosed by definitive biopsy, including fine
needle aspiration biopsy (FNAB), core biopsy, or
subtotal removal of a single node. Microscopic
examination by a pathologist is necessary to
identify the molecular, cellular or architectural
characteristics of the epithelial tissue. Carcinoma
cancer cell structure has a large nucleus size,
round monotone and has abundant cytoplasm.
Microscopically, an adenocarcinoma can be
seen with various glandular arrangements and
cell types, some containing excessive mucin in
the cytoplasm to be called signet-ring cells or
forming so much mucin that it is called mucoid
carcinoma.1,3
Prompt diagnosis and management help
reduce the risk of dying from colorectal cancer.
Appropriate diagnosis can be assisted by
Y Andila, et al: Comparison between the Effectiveness Fecal Immunochemical Test and Colonoscopy As A Tool For Colorectal Cancer
Early Detection
early detection of patients suspected of having
colorectal cancer symptoms. Apart from being
the first step in establishing a diagnosis, early
detection also aims to remove the lesion pre-
cancer and specifically detects disease at an early
stage so that curative therapy can be performed.4
Early detection of colorectal cancer is
primarily indicated in patients with the
following conditions: individuals with history
of adenomatous polyps, individuals with a
history of colorectal cancer curative resection,
individuals with first-degree relatives with
history of colorectal cancer or colorectal
adenoma (recommendations differ based on
family age at diagnosis), individuals with a
long history of inflammatory bowel disease.
Individuals with a diagnosis or suspicion of
hereditary nonpolyposis colorectal cancer
(HNPCC) syndrome or Lynch syndrome or
familial adenomatous polyposis (FAP).5
In general, there are 2 types of early
detection that can be done, namely Stool Based
Test and Structural Exams. In the Stool Based
examination, the sample used is feces by looking
at several components that may appear. This
test is considered non-invasive, easy to do but
should be done more often. In addition, this
examination will still require confirmation
through examination visual (structural) exams if
abnormal results are found.6
One of the best ways to check for cancer is
to look for blood in the stool. This is because
in cases of colorectal polyps or colorectal
cancer there will be neovascularization that is
fragile and will be very easily damaged when
feces pass through these lesions. But often the
resulting blood cannot be seen with the naked
eye. Examination of fecal immunochemical test
(FIT) is one method of assessing the presence or
absence of blood in the stool. This check is easier
to do but must be done every year.6
The FIT examination has several differences
compared to the fecal occult blood test (FOBT)
which is also included in the Stool Based Test..
In the FIT examination, it is not necessary to
do a special diet, or treatment must be stopped
first because vitamins and food will not affect
the results of the examination. This examination
is also less responsive to upper gastrointestinal
bleeding so the possibility of bias due to other
bleeding is lower.7
The sampling procedure of the FIT can also
be performed independently by the patient.
Patients will be provided with the necessary
equipment for sampling such as test kits, test
52
cards/tubes, long brushes/collecting devices,
and waste bags.8
Meanwhile, colonoscopy, which is one of the
modalities of Structural Exams, can be performed
by looking at the colon and rectum using a
colonoscope. A colonoscope is a flexible tube
about the size of a finger with a video camera at
the end. The colonoscope is inserted through the
anus into the rectum and colon. This colonoscope
is also accompanied by an instrument to take
samples if needed.7
Based on its advantages, FIT has advantages
in the form of no risk of trauma to the colon
because the examination is not invasive, no
special preparation is needed, the sampling
process is easier to do and can be done at
home, and cheaper. However, there are some
drawbacks to FIT, such as not being able to
detect some types of polyps and cancer, it can
give results false positive, it must be done every
year and a colonoscopy should still be done if
abnormal results are found.6,18 On the other hand,
colonoscopy is still considered to be the most
accurate test for early detection and prevention
of colorectal cancer but also has constraints in
terms of cost and patient convenience. The aim of
study, interested in comparing the effectiveness
of the fecal immunochemical test (FIT) against
colonoscopy. as an early detection tool for
colorectal cancer.
Methods
This study was conducted at Dr. Hasan Sadikin
Bandung General Hospital during the period
January 2021–April 2021 with the subject were
adult colorectal cancer patients aged more than
18 years who came to the Digestive Surgery
Department of Dr. Hasan Sadikin Bandung
General Hospital which meet the inclusion
criteria and did not include the exclusion
criteria. This study consisted of independent
variables in the form of FIT and colonoscopy
as an early detection tool and the effectiveness
of each therapy as the dependent variable.
This research procedure was approved by the
Health Research Ethics Committee No.LB.02.01/
X.6.5/300/2021,Universitas Padjadjaran
Bandung.
This study was an observational analytic
diagnostic test study using a cross-sectional
design that aimed to compare the effectiveness
of the fecal immunochemical test (FIT) against
colonoscopy. as an early detection tool for
Majalah Kedokteran Bandung, Volume 54, Number 1, March 2022
Y Andila, et al: Comparison between the Effectiveness Fecal Immunochemical Test and Colonoscopy As A Tool For Colorectal Cancer
Early Detection
colorectal cancer.
This study was conducted on patients
who had symptoms of colorectal cancer with
an affordable population including patients
undergoing examination and treatment at the
Digestive Surgery Department of Dr. Hasan
Sadikin Bandung General Hospital. Research
subjects must be patients with suspected
colorectal cancer and a high risk of colorectal
cancer, aged more than 18 years and willing to
participate in the study for a predetermined
period of time after has been informed consent
obtained. The exclusion criteria in this study
were patients who had undergone surgery and
patients who were undergoing or had completed
chemotherapy.
The minimum sample size was determined
based on the sample size formula for diagnostic
tests with a 95% confidence interval. Meanwhile,
colonoscopy’s sensitivity method was 90%. So
that the minimum number of samples needed
was 35 patients, added 10% to avoid sample
shortages due to drop out so that it became 38
patients. The sampling technique was carried
out by consecutive sampling, namely based
on the order of arrival of patients who met the
inclusion criteria until the minimum sample size
was met. Determination of the sample starts
from the selection of members of the population
against the inclusion and exclusion criteria.
Where the selected sample was a sample that
can be reached by researchers and has met the
inclusion criteria and exclusion criteria.
All research subjects were examined by
history taking and physical examination related
to colorectal cancer. Physical examination was
also assessed to help diagnose colorectal cancer.
Subsequent research subjects underwent FIT
examination and colonoscopy to diagnose
suspected colorectal cancer.
The analysis carried out was a diagnostic test to
obtain sensitivity, specificity, positive predictive
value (PPV), and negative predictive value
(NPC). then bivariate analysis was performed/
conducted using chi square difference test to
compare the incident of colorectal cancer cases
between the group who used FIT with those who
used colonoscopy for screening. The hypotheses
were tested using Mann-Whitney U test. The
results of statistical tests were said to be
meaningful if the p value was less than 0.05. The
data obtained were recorded in a special form
and then processed through the SPSS version
21.0 program for Windows.
Majalah Kedokteran Bandung, Volume 54, Number 1, March 2022
Results
During the period of January 2021–April
2021, 38 patients with symptoms resembling
colorectal cancer were examined and treated
at the Digestive Surgery Department, Dr. Hasan
Sadikin Bandung General Hospital, with details
as many as 27 people were colorectal cancer
patients and 11 patients who were not colorectal
cancer but have colitis. The following table was
the result of the identification of the research
subject characteristics totaling 38 patients.
Based on Table 1, it can be seen that the age
of the majority of research subjects was in the
range of 56–65 years with 12 of 38 patients. Then
the second place, namely the age range of 46–55
years, totaling nine patients were in the age
range of 46–55 years, and only 1 patient in the
lowest age range (17–25 years), only 1 person .
When viewed by gender, 20 of 38 of patients. A
total of 29 of 38 people had comorbidities. There
were several risk factors in patients, include the
most combination of age, physical activity, diet
and smoking. These factors was a higher when
compared to other risk factors.
Analysis of hypothesis testing was carried
out using the Mann Whitney test comparison.
Then tested for sensitivity, specificity, positive
predictive value (PPV), and negative predictive
value (NPV). The following was a recapitulation
of the hypothesis testing result.
Based on the recapitulation of the results in
Table 2, it can be seen that the p-value of the Mann
Whitney test showed 0.624. Because the p-value
>0.05 means that there was no statistically
significant difference in the effectiveness of the
fecal immunochemical test on colonoscopy as
a screening tool for colorectal cancer. In other
words, the results of the FIT were almost the same
as the results of the dolonoscopy. The sensitivity
level of the FIT was 81.5%, the specificity level
was 72.7%, the PPV value was 88% and the NPV
value was 61.5%. Thus, the research hypothesis
can be accepted where there was no significant
difference between the effectiveness of the Fecal
Immunochemical Test against Colonoscopy as a
screening tool for colorectal cancer.
Discussion
FIT and colonoscopy were two modalities that
can be used as methods of early detection of
colorectal cancer. FIT has advantages in the
form of no risk of trauma to the colon because
the examination is not invasive, no special
preparation is needed, the sampling process is
53
Y Andila, et al: Comparison between the Effectiveness Fecal Immunochemical Test and Colonoscopy As A Tool For Colorectal Cancer
Early Detection

Table 1 Characteristics of Research Subjects

Variable Total
Age (Years) 17-25 1
26-35 5
36-45 4
46–55 9
56–65 12
>65 Years 7
Gender Male 18
  Female 20
Comorbid Yes 29
  No 9
Risk factors Physical activity, diet 1
Diet 5
Hereditary factors 1
Hereditary factors, diet 1
Smoking 3
Smoking and age 1
Smoking, diet 2
Age 6
Age , Physical activity 4
Age, Diet 5
Age, Hereditary factors, diet 1
Age, smoking 3
Age, Smoking 4
  Age, smoking, Diet 1

Table 2 Sensitivity, Specificity, PPV and NPV of FIT and Colonoscopy Examination
FIT
Colonoscopy Total
Positive Negative
Positive 22 5 27
Negative 3 8 11
Total 25 13 38

Sensitivity Specificity PPV NPV Kappa p-value*

81.5% 72.7% 88.0% 61.5% 0.514 0.624

*) p-value mann whitney test

54 Majalah Kedokteran Bandung, Volume 54, Number 1, March 2022

Y Andila, et al: Comparison between the Effectiveness Fecal Immunochemical Test and Colonoscopy As A Tool For Colorectal Cancer
Early Detection
easier to do and can be done at home, cheaper.
In addition, a study conducted by Segnan et al. in
2007 has shown that semiquantitative FIT was
more accurate than the guaiac test for detecting
advanced colorectal cancer and adenoma, and
this new test was now recommended as the
fecal occult blood test first choice in the early
detection of colorectal cancer. However, there
were some limitations from FIT, such as not
being able to detect certain types of polyps and
cancer, it can give false positive results, The rates
of false-negative and false-positive of FIT were
58.0% and 15.7%. it must be done every year and
a colonoscopy should still be done if abnormal
results are found.7
Colonoscopy on the other hand was still the
gold standard in detecting colorectal cancer
and was recommended as the first line for early
detection because its accuracy was still higher
than other tests. However, colonoscopy still
has several disadvantages, including costs that
are not cheap and are more invasive which in
turn will reduce patient comfort and patient
compliance in carrying out the examination.9
The balance between invasive and non-invasive
examinations was considered to have an
important role in increasing patient compliance
for early detection for further diagnosis.10,11
Although both can be used as an early
detection tool and was quite sensitive in
detecting colorectal cancer lesions, but fecal
immunochemical test has a limited function
in detecting pre-cancerous lesions compared
to colonoscopy. However, if FIT is as effective
as colonoscopy the use of this test as an early
detection tool can reduce the cost burden
significantly.12,13
The results of this study were similar to
those of Enrique et al. who also described that
there was no significant difference between
colonoscopy and FIT. Meanwhile differing
5
results obtained in studies conducted Amanda,
et al that FIT can reduce the use of colonoscopy
to 71%, but can miss cases of colorectal cancer
up to 30–40% of cases.14
In a study conducted by Zorzi et al.
Colonoscopy was known to more accurately
describe the type of cancer and the stage of
cancer that occurs in patients. The results of the
study stated that there were 3.9% of patients
suffering from colorectal cancer, of which 24.8%
had a high risk of developing an adenoma and
18.7% a low risk of developing an adenoma. As
for the stage of colorectal cancer can be detected
in 64.8% of patients, and obtained patients
with the condition of stage I as many as 48.6%
Majalah Kedokteran Bandung, Volume 54, Number 1, March 2022
and stage II as many as 34.5%. Limitations
of this study was the site of neoplasms that
are not described further even though the
actual location of the neoplasm may affect the
sensitivity and specificity of both the early
detection tool. Colonoscopy and FIT were known
to be less effective in detecting lesions located in
the proximal colon than in the distal colon.2,15
From the results of research on the
comparison of the effectiveness of the FIT
against Colonoscopy as an early detection tool for
colorectal cancer, it was known that there was no
significant difference between the effectiveness
of the FIT against colonoscopy as a screening
tool for colorectal cancer.
This study can be further developed, with
more samples, more variables such as the type
of lesion, whether pre-cancerous or cancerous,
described in more detail and then the location
of the neoplasm can also be added because the
sensitivity and specificity of FIT and colonoscopy
are influenced by other factors. that factor.
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